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Sr Manager, Regulatory Affairs - Strategy

Company: Horizon Therapeutics
Location: Rockville
Posted on: November 14, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary:

This position is responsible for the regulatory support of products marketed in the U.S., E.U., and rest-of-the-world (ROW) as well as development stage products. This position is also responsible for coordinating all aspects of regulatory submissions for assigned projects, providing guidance on post-approval changes, assisting in developing regulatory strategy, and representing the function on cross-functional teams.

Responsibilities:

* Assist in the development and implementation of regulatory strategies for investigational

and commercial drug products

* Provide required regulatory documentation for health authority submissions and

subsequent amendments/variations/supplements

* Provide oversight of clinical research organizations managing rest of world regulatory

submissions and correspondences

* Assist in providing guidance on the content and suitability of regulatory documents for

submission

* Assist in providing interpretative analyses of complex regulatory guidance documents,

regulations, or directives that impact the company's products and operations

* Manage project deliverables and timelines and ensures all assignments meet regulatory and

other company guidelines

* Assist in providing input into the response strategy for health authority queries

* Draft responses to health authority queries, track responses and regulatory commitments

* Participate in regulatory agency inspections, as required

* Keep abreast of industry trends with respect to regulatory policies and procedures within

the EU, US, and ROW

* Ensures quality and compliance of regulatory activities by adhering to established corporate

and functional processes, guidelines and SOP's

* Cultivates relationships with key colleagues in other parts of the organization

* Mentors, develops, and assesses direct reports including monitoring and managing

workload and assignments if applicable

Qualifications and Skills Required

* Minimum BA/BS in related scientific discipline (biology, chemistry, biochemistry, immunology,

pharmacy)

* 5-9 years regulatory affairs experiences preferably involving direct contact with regulatory

agencies, full knowledge of FDA, EU and ICH regulations and guidelines and the ability to assist

in providing interpretation of the information to others.

* Preferred knowledge and experience with the regulatory process for approval of both biologics and small molecule products

* Demonstrated ability to work and draft documents in a fast-paced environment

* Flexible with respect to prioritization of daily tasks and projects according to internal and

external influences

* Strong organizational skills and attention to detail

* Excellent written and verbal communication skills

Horizon Core Values & Competencies:

Growth

  • Manages Ambiguity
  • Strategic Mindset
  • Demonstrates Self-awareness
  • Cultivates Innovation
  • Develops Talent

    Accountability
    • Drives Results
    • Ensures Accountability
    • Decision Quality

      Transparency
      • Courage
      • Collaboration
      • Instills Trust

        Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Keywords: Horizon Therapeutics, Rockville , Sr Manager, Regulatory Affairs - Strategy, Executive , Rockville, Maryland

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